Tramal Retard 150

Leaflet accompanying the packaging: patient information

Tramal Retard 100, 100 mg, prolonged-release tablets

Tramal Retard 150, 150 mg, prolonged-release tablets

Tramal Retard 200, 200 mg, prolonged-release tablets

Tramadol hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Tramal Retard 100, Tramal Retard 150, Tramal Retard 200 and what is it used for
• 2. Important information before taking Tramal Retard 100, Tramal Retard 150 or Tramal Retard 200
• 3. How to take Tramal Retard 100, Tramal Retard 150, Tramal Retard 200
• 4. Possible side effects
• 5. How to store Tramal Retard 100, Tramal Retard 150, Tramal Retard 200
• 6. Package contents and other information

1. What is Tramal Retard 100, Tramal Retard 150, Tramal Retard 200 and what is it used for

what it is used for
Tramadol, the active substance of Tramal Retard 100, Tramal Retard 150, Tramal Retard 200, is a pain-relieving substance belonging to the group of opioids that affect the central nervous system.
It has a pain-relieving effect by acting on specific receptors of nerve cells in the spinal cord and brain.
Tramal Retard is indicated for the treatment of moderate to severe pain.

2. Important information before taking Tramal Retard 100, Tramal Retard 150 or Tramal Retard 200

When not to take Tramal Retard:

• in case of acute alcohol poisoning, sleeping pills, painkillers, or psychotropic drugs (drugs that affect mood and emotions);
• in case of concurrent treatment with MAO inhibitors (certain antidepressants) and for 14 days after their discontinuation (see "Tramal Retard and other medicines");
• in patients with uncontrolled epilepsy;
• for the treatment of opioid dependence.

Warnings and precautions

Before starting treatment with Tramal Retard, you should consult a doctor:

• in case of dependence on other pain-relieving substances (opioids);
• in case of impaired consciousness (if the patient feels fainting);
• in case of shock (cold sweats may be a symptom);
• in case of increased intracranial pressure (may occur after head injury or brain diseases);
• in case of respiratory disorders;
• in patients with increased sensitivity to opioid drugs;
• in patients with epilepsy or increased risk of seizures, as this risk is further increased;
• in patients with liver or kidney disease;

Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid drug. Repeated use of opioids can lead to decreased efficacy of the medicine (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Tramal Retard may also lead to dependence, abuse, and addiction, which can cause life-threatening overdose. The risk of these side effects may increase with the dose and duration of treatment.
Dependence or addiction can cause the patient to lose control over the amount of medicine taken or the frequency of its administration.
The risk of dependence on Tramal Retard may be higher in individuals in the following situations:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, or illegal drugs ("addiction");
• the patient is a smoker;
• the patient has ever had mood problems (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses. If the patient notices any of the following symptoms while taking Tramal Retard, it may indicate dependence or addiction.
• The need to take the medicine for a longer period than recommended by the doctor.
• The need to take a higher dose than recommended.
• The patient uses the medicine for reasons other than those for which it was prescribed, such as "to calm down" or "to sleep better".
• The patient has made repeated, unsuccessful attempts to stop or control the use of the medicine.
• After stopping the medicine, the patient feels unwell, and after taking it again, they feel better ("withdrawal symptoms"). If the patient notices any of these symptoms, they should consult a doctor to discuss the best treatment option, including deciding when to stop taking the medicine and how to do it safely (see section 3, Stopping Tramal Retard).

Respiratory disorders during sleep
Tramal Retard 100, 150, and 200 may cause respiratory disorders during sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood) .Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, they should contact a doctor. The doctor may recommend reducing the dose.
Caution should be exercised in patients with impaired respiratory function, who are also taking medicines that depress the central nervous system (see Tramal and other medicines) or in case of taking higher doses than recommended (see "Taking a higher dose of Tramal Retard" in section 3 and section 4), as in such cases, respiratory depression cannot be ruled out.
Seizures have been observed in patients taking tramadol in recommended doses.
The risk of seizures may be higher if the tramadol dose exceeds the recommended maximum daily dose (400 mg) or if the patient is taking other medicines that lower the seizure threshold (see "Tramal Retard and other medicines").
Tramal Retard may cause physical and psychological dependence. Long-term use of Tramal Retard may lead to decreased efficacy of the medicine, resulting in the need for higher doses (development of tolerance). In case of a tendency to abuse medicines or addiction, treatment should be short-term and under close medical supervision.
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, the patient should contact a doctor, who will decide whether the patient needs hormone replacement therapy.
The patient should consult a doctor if they experience any of the above situations while taking Tramal Retard, even if these warnings refer to situations that occurred in the past.
Tramadol is metabolized in the liver by an enzyme. In some individuals, there is a certain variant of this enzyme, which can have different effects. In some individuals, pain relief may not be sufficient, and in others, serious side effects are more likely to occur.
The patient should stop taking the medicine and immediately consult a doctor if they experience any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Tramal Retard and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tramal Retard should not be taken concurrently with MAO inhibitors (medicines used to treat depression) and for 14 days after their discontinuation.
The pain-relieving effect of Tramal Retard may be reduced, and the duration of action may be shortened if taken concurrently with medicines containing:

• carbamazepine (an antiepileptic drug),
• pentazocine, nalbuphine, or buprenorphine (pain-relieving medicines),
• ondansetron (an antiemetic medicine). The patient should consult a doctor about taking Tramal Retard and its dosage.

The risk of side effects increases:

• when Tramal Retard is taken concurrently with other pain-relieving medicines, such as morphine and codeine (also as a cough medicine), and alcohol. Drowsiness or fainting may occur. In such cases, the patient should consult a doctor.
• when Tramal Retard is taken concurrently with sedative or sleeping medicines (e.g., benzodiazepines) or gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain. The risk of drowsiness, breathing difficulties (respiratory depression), coma, and life-threatening conditions increases.

Concomitant use should only be considered if other treatment options are not possible. However, if a doctor prescribes Tramal Retard with sedative medicines, the dose and treatment duration should be limited by the doctor.
The patient should inform their doctor about all sedative medicines they are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact a doctor.

• in case of concurrent use of anticoagulant medicines, such as warfarin, with Tramal Retard. Bleeding may occur due to the effect of these medicines on blood coagulation.

Ketoconazole (an antifungal medicine) and erythromycin (an antibacterial medicine) may inhibit the metabolism of tramadol and its active metabolite.

Tramal Retard with food, drink, and alcohol

The patient should not drink alcohol while taking Tramal Retard, as the effect of the medicine may be enhanced, leading to respiratory depression.
Food does not affect the efficacy of Tramal Retard.

Children and adolescents

Use in children with respiratory disorders

Tramadol should not be used in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them.
Pregnancy, breastfeeding, and fertility:
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
The safety of tramadol use during pregnancy has not been established. Therefore, Tramal Retard should not be used during pregnancy.
Prolonged administration of tramadol during pregnancy may lead to the development of withdrawal syndrome in the newborn.
Breastfeeding
Tramadol is excreted into breast milk. Therefore, Tramal Retard 100, 150, and 200 mg should not be taken more than once, or if Tramal Retard 100, 150, or 200 mg has been taken more than once, breastfeeding should be discontinued.
Human experience with tramadol does not indicate that it affects fertility in women and men.

Driving and operating machinery

Tramal Retard may cause drowsiness, dizziness, and blurred vision, which may affect reaction time. Therefore, the patient should not drive vehicles or operate machinery.

Tramal Retard contains lactose

In case of intolerance to certain sugars, the patient should consult a doctor before taking the medicine. This medicine contains lactose.

3. How to take Tramal Retard 100, Tramal Retard 150, Tramal Retard 200

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Tramal Retard, when and how long to take it, when to contact the doctor, and when to stop taking the medicine (see also section 2).
The doctor will adjust the dose according to the severity of the pain and the patient's individual response to treatment. This will be the smallest dose that effectively relieves the pain. The patient should not take more than 400 mg of tramadol hydrochloride per day, unless the doctor recommends otherwise.
Unless the doctor recommends otherwise, the following dosing is usually used:
Adults and adolescents over 12 years of age:
One Tramal Retard 100 tablet twice a day (equivalent to 200 mg of tramadol hydrochloride), preferably in the morning and evening.
or
One Tramal Retard 150 tablet twice a day (equivalent to 300 mg of tramadol hydrochloride), preferably in the morning and evening.
or
One Tramal Retard 200 tablet twice a day (equivalent to 400 mg of tramadol hydrochloride), preferably in the morning and evening.
If necessary, the doctor may recommend a different, more tailored dosing of Tramal Retard.
If necessary, the dose may be increased to 150 or 200 mg twice a day (equivalent to 300 mg to 400 mg of tramadol hydrochloride per day).
Children:
Tramal Retard should not be used in children under 12 years of age.
Elderly patients:
In patients over 75 years of age, tramadol elimination may be delayed. In these patients, the doctor may recommend prolonging the time interval between doses.
Patients with renal or hepatic impairment:
Tramal Retard should not be taken in case of severe hepatic or renal impairment.
In case of mild or moderate impairment, the doctor may recommend prolonging the time interval between doses.
Method of administration:
Tramal Retard should be taken orally.
The tablet should always be taken whole, with a small amount of liquid, and should not be divided or crushed. It can be taken with or without food.
Duration of treatment:
Tramal Retard should not be taken for longer than absolutely necessary. In case of necessity for long-term treatment due to the type and severity of the disease, the doctor will regularly monitor the patient's condition (interrupting treatment for a period of time if necessary), to determine whether and at what dose Tramal Retard treatment should be continued.
If the patient feels that the effect of Tramal Retard is too strong or too weak, they should consult a doctor or pharmacist.

Taking a higher dose of Tramal Retard 100, Tramal Retard 150, Tramal Retard 200:

After taking higher doses than recommended, the following may occur: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, collapse, impaired consciousness up to coma (a state of deep loss of consciousness), seizures, respiratory depression up to respiratory arrest.
In such cases, the patient should immediately consult a doctor!

Missing a dose of Tramal Retard

If the patient forgets to take the medicine at the right time, the pain symptoms will likely return.
The patient should not take a double dose to make up for the missed dose.
The patient should return to the previous dosing schedule.

Stopping Tramal Retard

In case of sudden stopping or premature discontinuation of Tramal Retard, the pain symptoms will likely return.
If the patient wants to stop treatment due to side effects, they should inform their doctor.
The patient should not suddenly stop taking the medicine without the doctor's recommendation. If the patient wants to stop taking the medicine, they should discuss it with their doctor, especially if the medicine has been taken for a long time.
The doctor will advise on when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms).
Generally, after stopping Tramal Retard, no serious side effects are observed. However, in rare cases, after sudden discontinuation of Tramal Retard taken for a certain period, the patient may feel unwell. They may experience agitation, anxiety, nervousness, tremors, excessive restlessness, difficulty sleeping, and gastrointestinal or intestinal disorders.
Very rarely, the following may occur: panic attacks, hallucinations, abnormal perception of stimuli, such as itching, tingling, numbness, and tinnitus.
Other unusual central nervous system disorders, such as confusion, delusions, depersonalization, derealization, and paranoid delusions, have occurred very rarely.
If the patient experiences any of these symptoms after stopping the medicine, they should immediately consult a doctor.
If the patient has any further doubts about taking the medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramal Retard can cause side effects, although not everybody gets them.

The patient should immediately consult a doctor if they experience any symptoms of allergic reactions, such as:

swollen face, tongue, and/or throat, and/or difficulty swallowing or hives accompanied by difficulty breathing, low blood pressure, weakness, fainting

• - occurring in 1 to 10 out of 10,000 patients.

The most common side effects reported in more than 1 in 10 people during treatment with Tramal Retard were nausea and dizziness.
Very common
(occurring in more than 1 in 10 people):
dizziness,
nausea.
Common
(occurring in 1 to 10 out of 100 people):
headache, drowsiness,
vomiting, constipation, dry mouth,
excessive sweating,
fatigue.
Uncommon
(occurring in 1 to 10 out of 1,000 people):
heart and circulatory disorders (palpitations, rapid heartbeat, feeling of weakness due to decreased blood pressure in patients changing body position from lying to standing and collapse). Such side effects may occur especially during intravenous administration of tramadol and in patients after physical exertion.
Vomiting, stomach and intestinal irritation (feeling of pressure in the stomach, bloating), diarrhea,
skin reactions (e.g., itching, rash, hives).
Rare
(occurring in 1 to 10 out of 10,000 people):
slow heartbeat,
increased blood pressure,
changes in appetite,
slow breathing, "short breath" (shortness of breath).
Asthma exacerbation has been reported during tramadol treatment, although a causal relationship between these facts has not been established. In case of taking doses significantly higher than recommended and concurrent use of other medicines that depress the central nervous system (e.g., sedatives, sleeping pills, other pain-relieving medicines, alcohol), respiratory depression may occur.
Abnormal sensation (e.g., itching, tingling, numbness), tremors, seizures, muscle spasms, uncoordinated movements, fainting, speech disorders;
Seizures occur mainly after taking high doses of tramadol and in case of concurrent use of other medicines that may cause seizures;
Hallucinations, confusion, sleep disorders, delirium, anxiety, and nightmares. After taking Tramal, psychiatric disorders may occur. Their severity and type may vary (depending on the patient's personality and treatment duration). These may include mood disorders (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), and decreased sensory and cognitive perception (changes in sensation and recognition, which may lead to incorrect assessment of the situation);
The medicine may cause dependence.
After sudden discontinuation of treatment, withdrawal symptoms may occur (see "Stopping Tramal Retard");
Pupil constriction (miosis), blurred vision, excessive pupil dilation (mydriasis),
muscle weakness;
urination disorders or pain while urinating, decreased urine output (urinary retention);
allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure);
Very rare
(occurring in less than 1 in 10,000 people):
increased liver enzyme activity.
low blood sugar, hiccups, serotonin syndrome, whose symptoms may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramal Retard").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tramal Retard 100, Tramal Retard 150, Tramal Retard 200

The medicine should be stored out of sight and reach of children.
This medicine should be stored in a closed and secure place, inaccessible to other people. It can cause serious harm and be life-threatening to individuals for whom it has not been prescribed.
The medicine should not be taken after the expiration date stated on the packaging. The expiration date refers to the last day of the given month.
There are no special storage precautions.
Unknown (frequency cannot be estimated from available data):
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tramal Retard 100 contains

• The active substance of Tramal Retard is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 100 contains 100 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• Other ingredients of the medicine are: tablet core: hypromellose 100 000 mPas, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose. coating: hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide.

What Tramal Retard 150 contains

• The active substance is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 150 contains 150 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• Other ingredients of the medicine are: tablet core: hypromellose 100 000 mPas, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose. coating: hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide, iron oxide red (E 172), quinoline yellow lake (E 104).

What Tramal Retard 200 contains

• The active substance is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 200 contains 200 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• Other ingredients of the medicine are: tablet core: hypromellose 100 000 mPas, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose. coating: hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide, iron oxide red (E 172), iron oxide brown (E 172), quinoline yellow lake (E 104).

What Tramal Retard 100, Tramal Retard 150, Tramal Retard 200 look like and what the package contains:

Tramal Retard 100: white, round, with "T1" embossed on one side, and the manufacturer's logo  on the other side.
Tramal Retard 150: pale orange, round, with "T2" embossed on one side, and the manufacturer's logo  on the other side.
Tramal Retard 200: light brown with an orange tint, round, with "T3" embossed on one side, and the manufacturer's logo  on the other side.
Packages contain 10, 30, or 50 tablets in blisters of 10, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Date of last revision of the leaflet: 05/2024